tinea pedis (interdigital, Athlet´s foot)
Conditions
Interventions
Product Name: Dermopid
Pharmaceutical Form: Cream
Trade Name: Lamisil
Product Name: LAMISIL
Pharmaceutical Form: Cream
Sponsors
JELFA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • clinical diagnosis of tinea pedis confirmed by microscopy and culture; detection of fungal hyphae • age 18 + Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • prior radiotherapy or immunosuppressive therapy • antimicrobial therapy within 2 weeks • the presence of systemic fungal disease • chronic plantar tinea pedis • the presence of bacterial infection • application of topical antifungals within 28 days • concurrent onychomycosis • pregnancy and breasfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of two terbinafine products in patients with tinea pedis and to show therapeutic equivalence between test product (TERBINAFINE 1% cream, Jelfa SA) and reference product (LAMISIL 1% cream, Novartis).;Secondary Objective: ;Primary end point(s): mycological cure, defined as negative microscopy and culture at the end of the study (week 4) – visit 3 | — |
Countries
Czech Republic
Outcome results
None listed